Protocol summary
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Study aim
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Comparison of the effect of dual-task exercise v.s combined exercise in water and land on balance and gait of patients with multiple sclerosis.
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Design
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RCT with the control group, the double-blinded factorial group on 78 patients. Participants will be randomized using block randomization at http://randomizer.org/.
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Settings and conduct
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This study focuses on exercise therapy on people with multiple sclerosis as pre-test and post-test. gait biomechanics analysis tests in the laboratory, cognitive and movement tests are evaluated pre and post twelve-week treatment. The movement biomechanics laboratory, swimming pool, and gym will be at the Khwarazmi University of Karaj. outcome assessor who does not know the hypothesis and study methods will be blinded to group allocation, also the data analysts will analyze the information of individuals in a code format.so he will be blinded too.
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
patients with relapsing-remitting type, The (EDSS) should be between 1.0 and 5.5.
exclusion criteria:
Inability to stand and walk without aids.
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Intervention groups
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1. Intervention group: dual-task exercise in water: dual-task exercise will be done in the swimming pool.
2. Intervention group: dual-task exercise on land: dual-task exercise will be done in the gym.
3. Intervention group: combined exercise in water: combined exercise will be done in the swimming pool.
4. Intervention group: combined exercise on land: combined exercise will be done in a gym
5. Control group: patients with multiple sclerosis walking in water.
6. Control group: patients with multiple sclerosis walking in land.
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Main outcome variables
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static and dynamic Balance rate; gait biomechanics.
General information
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Reason for update
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This study underwent changes after the time of registration due to the following reasons:
1. Because the type of study was changed from parallel to factorial, the researchers should have added another control group to the study so that the factorial type was 3-2-2 In this case, even the environmental factor was properly investigated in the study. so the participant number increased from 65 to 78.
2. Participants genders changed from only women to both
3. the primary and the secondary outcome exchanged, Because the statistical error will be reduced.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210614051581N1
Registration date:
2023-01-25, 1401/11/05
Registration timing:
prospective
Last update:
2023-09-14, 1402/06/23
Update count:
1
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Registration date
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2023-01-25, 1401/11/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-28, 1401/11/08
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Expected recruitment end date
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2023-02-04, 1401/11/15
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Actual recruitment start date
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2023-01-30, 1401/11/10
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Actual recruitment end date
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2023-02-15, 1401/11/26
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of dual task exercise versus combined exercise in water and land on balance and gait of patients with multiple sclerosis.
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Public title
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effect of exercise treatment in patients with multiple sclerosis.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients with relapsing remitting type of multiple sclerosis.
No MS relapse occurred within eight weeks prior to the inclusion
Status Scale (EDSS) score ranging from 1.0 to 5.5
lack of regular physical exercise
Exclusion criteria:
being unable to comply with the requirements of the protocol.
Inability to stand and walk without aids and braces.
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
78
Actual sample size reached:
78
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: block randomization
Randomization unit: it is individual.
Randomization type: Randomization will be online randomization using the website http://randomizer.org/. Patients who meet the inclusion criteria will be randomly assigned to the experimental group (exercise in water and exercise on land) and the control groups. In this site, first, the number of sets of random numbers that is needed is determined (six sets of numbers are needed; 1. experimental group A, 2. experimental group B, 3. experimental group C, 4. experimental group D, 5. group Control E, and 6. control group F). The numbers that Research Randomizer needs to generate in each set are determined (six sets of 13 numbers are needed for each group). We specify the minimum and maximum amount of numbers that need to be produced (from 1 to 78).
Concealment: Concealment of random assignment using a block randomization table (blocks of 10) generated by computer (number 1 for experimental group 1, number 2 for experimental group 2, number 3 for experimental group 3 and number 4 for experimental group, number 5 for control group and number 6 for control group) will be done before the start of data collection by a researcher who will not participate in calling or treating patients.
Randomization tool: Random numerical sequence is placed in non-transparent and sealed envelopes. Another investigator, blinded to the initial assessment, will open an envelope and proceed with treatment as assigned by the group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study,is doubled blinded, and the outcome assessor and the data analyst will be blind (uninformed) regarding the allocation of groups. Patients will be aware of the type of study.
Outcome assessor : In this study, an independent evaluator who does not know the hypothesis and methods of the study will evaluate the results before the interventions and 12 weeks after the interventions.
Data analyst: The data analyst is blinded. the collected data will be matched with the codes given to each patient. so, the data analyst will see each patient in the form of a code, and the grouping of patients will not be recognizable to him.
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-21, 1401/08/30
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Ethics committee reference number
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IR.SSRC.REC.1401.082
Health conditions studied
1
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Description of health condition studied
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multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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the brief repeated battery of neuropsychological tests
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Timepoint
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before and after intervention
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Method of measurement
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psychological and cognitive test
2
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Description
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dual task rate
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Timepoint
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before and after intervention
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Method of measurement
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dual task questionaire
Secondary outcomes
1
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Description
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static and dynamic Balance rate
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Timepoint
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before intervention and after intervention
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Method of measurement
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force plate and motion analyze instrument
2
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Description
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biomechanic gait including movement angles and forces on the ground, which may change with intervention.
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Timepoint
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before intervention and after intervention
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Method of measurement
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force plate and motion analyze instrument
3
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Description
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evaluation of electromyography during tasks
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Timepoint
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before intervention and after intervention
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Method of measurement
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electromyography instrument
Intervention groups
1
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Description
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Intervention group: dual-task exercise in water Dual task exercises are exercises in which both cognitive and motor exercises are prescribed to the patient. For example, walking in water while deducting seven numbers from the number 129. Dual task exercises in water are first presented separately in the form of single cognitive exercises, then in the form of movement exercises and finally by combining both of these exercises, dual task exercises are presented to the subject. These exercises are performed in a swimming pool depth of 120 cm and at a water temperature of 30 to 31. The ambient temperature of the pool will be maintained around 26 to 28 degrees Celsius. These exercises last two days a week for 12 weeks (24 sessions) for one hour in each session.
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Category
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Rehabilitation
2
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Description
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Intervention group: dual task exercise on land These exercises are the same as the dual task exercises in the water, with the difference that they will be performed on land and in the gym.Dual task exercises are exercises in which both cognitive and motor exercises are prescribed to the patient. For example, walking in land while deducting seven numbers from the number 129. Dual task exercises inland are first presented separately in the form of single cognitive exercises, then in the form of movement exercises and finally by combining both of these exercises, dual task exercises are presented to the subject. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session.
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Category
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Rehabilitation
3
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Description
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Intervention group: combined exercise in water These exercises will also be performed in water, with the difference that instead of performing dual task, combined exercises (including strength, endurance and stretching exercises) will be used.Therefore, it is not a repetitive intervention. These exercises will be performed in water depth of 120 cm and at a water temperature of 30 to 31 degrees Celsius, and the pool's ambient temperature is maintained at 26 to 28 degrees Celsius. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. The specialist considers existing muscle weaknesses and balance defects to prescribe sports exercises. These deficits are determined based on manual muscle testing to assess weakness based on participant observation. All sessions begin with a 10-minute warm-up and end with a 5-minute cool-down. Joint stretching of the muscles plus specific stretching is done according to the specific needs of the participants. Combined exercises in the water include a strength, aerobic and balance training program.
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Category
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Rehabilitation
4
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Description
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Intervention group: combined exercise on land In this group, combined exercises are performed in the gym and on land. Therefore, it will not be a repeated intervention. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. The specialist considers existing muscle weaknesses and balance defects to prescribe sports exercises. These deficits are determined based on manual muscle testing to assess weakness based on participant observation. All sessions begin with a 10-minute warm-up and end with a 5-minute cool-down. Joint stretching of the muscles plus specific stretching is done according to the specific needs of the participants. Combined exercises in the water include a strength, aerobic and balance training program.
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Category
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Rehabilitation
5
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Description
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Control group: patients with multiple sclerosis walk in water. walking will also be performed in water, with no training protocole. walking in water will be performed in depth of 120 cm and at a water temperature of 30 to 31 degrees Celsius, and the pool's ambient temperature is maintained at 26 to 28 degrees Celsius. walking last two days a week in a period of 12 weeks (24 sessions) for one hour in each session.
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Category
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Rehabilitation
6
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Description
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Control group: patients with multiple sclerosis walk on land. walking will also be performed on land, with no training protocole. walking on land last two days a week in a period of 12 weeks (24 sessions) for one hour in each session
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kharazmi University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data files such as files related to the biomechanics of walking and motion analysis and gait tests, files related to EMG of worked muscles, dual-task questionnaires Balance scores and battery testsare the data that are examined in this study. will be. Data can potentially be shared after de-identifying individuals.
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When the data will become available and for how long
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The access period starts 6 months after the results are published in validate journals.
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To whom data/document is available
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Only researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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1. if the originality of the work is preserved and the names and information of the authors of this study are mentioned.
2. After the original data are published by the main researchers in a valid journal, permission is given to use the documents.
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From where data/document is obtainable
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saharnazary1992@gmail.com
saharnazary1992@khu.ac.ir
Sahar Nazary Soltan Ahmad
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What processes are involved for a request to access data/document
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After reading the email, the information will be sent to the researchers.
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Comments
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